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Efficacy of a Nutrition Biscuit in Malnutrition Management

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ClinicalTrials.gov Identifier: NCT03118089
Recruitment Status : Unknown
Verified April 2017 by University of Ulster.
Recruitment status was:  Enrolling by invitation
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of Ulster

Brief Summary:

The health risks and costs associated with malnutrition can be significantly reduced if symptoms are recognized early and treated effectively. Oral nutritional supplements (ONS) have been shown to increase nutrient intakes and maintain or improve nutritional status and functional outcomes in patients in a variety of settings. However despite this it is frequently reported that compliance to ONS, which are often milk based drinks, is poor. The aim of the present study is to assess the effectiveness of a new biscuit style nutritional supplement in the management of malnutrition.

The study is a randomized controlled eight-week intervention study. Suitable participants currently being prescribed ONS and who meet the study inclusion and exclusion criteria, will be identified by either staff in care facilities, Registered Dietitians or by General Practitioner (GP) surgeries. Participants (n=80) will be stratified based on BMI and gender and randomly assigned to either the biscuit ONS group (n=40) or to remain on their existing ONS prescribed as part of their standard care practice (n=40). Changes in anthropometry, functional status, nutritional intake and appetite, general health, gastrointestinal symptoms and biochemistry (correction of nutritional deficiency), as well as compliance and acceptability of ONS will be assessed between week 0 and week 8. Participants will also be visited mid-intervention (week 4) to ensure well-being and assess compliance.

This work is funded by Calerrific Ltd. and seeks to determine if the new biscuit style nutritional supplement could be used as an alternative to, or in conjunction with, existing ONS to improve compliance and aid the recovery of malnourished patients.


Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Biscuit style oral nutritional supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : September 1, 2014
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biscuit style oral nutritional supplement treatment
Participants will take the biscuit style oral nutritional supplement at an intervention level equivalent to their current oral nutritional supplement prescription
Dietary Supplement: Biscuit style oral nutritional supplement
No Intervention: Standard Care
Participants will remain on their current oral nutritional supplement



Primary Outcome Measures :
  1. Weight change [ Time Frame: Change over 8 weeks from baseline ]
    2% gain in 8 weeks where BMI<20kg/m2; prevention of further weight loss where BMI>20kg/m2


Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: Change over 8 weeks from baseline ]
    Hand grip strength

  2. Food intake [ Time Frame: Change over 8 weeks from baseline ]
    24-hour dietary recall

  3. General appetite [ Time Frame: Change over 8 weeks from baseline ]
    Likert scale assessment

  4. Gastrointestinal tolerance [ Time Frame: Change over 8 weeks from baseline ]
    Likert scale assessment

  5. Serum electrolytes [ Time Frame: Change over 4 weeks from baseline ]
  6. Biscuit palatability [ Time Frame: Change over 8 weeks from baseline ]
    Likert scale assessment

  7. Compliance [ Time Frame: Change over 8 weeks from baseline ]
    Self-reported diary



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently requiring oral nutritional supplement (minimum 8 weeks)

Exclusion Criteria:

  • Requiring tube or parenteral nutrition, texture modification or specialised diet
  • Diagnosed chronic renal or liver disease, diabetes T1, cancer cachexia
  • Any other condition whereby taking part in the study may have a negative impact on well-being

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118089


Locations
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United Kingdom
Northern Health and Social Care Trust
Londonderry, Co.Londonderry, United Kingdom
Sponsors and Collaborators
University of Ulster
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Responsible Party: University of Ulster
ClinicalTrials.gov Identifier: NCT03118089    
Other Study ID Numbers: 13/NI/1036
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Ulster:
Oral nutritional supplements
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders